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FDA designates recall of stroke revascularization device as Class I
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The FDA has designated Penumbra’s product recall of a device used in revascularization for acute ischemic stroke as a Class I recall, the most serious kind.
According to a safety alert from the agency, the delivery wire of the device (Penumbra 3D Revascularization) may separate or break while removing thrombus in the brain or restoring blood flow in patients with ischemic stroke who are not eligible or are unsuccessful with IV tissue plasminogen activator therapy. Retrieving pieces of the broken wire left inside the patient’s brain bloodstream may worsen the stroke. Other serious adverse events that may occur include completion of the stroke, continued blockage of blood vessels and death, according to the FDA.
Penumbra distributed a voluntary removal notice on June 9, 2017, alerting customers to identify affected devices and complete a form regarding the device. The company will make arrangements to return affected units and replace them, according to the FDA’s alert.